BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA®

    MDR report key: 24364442 · Received February 17, 2026

    Report

    Report Number
    9612501-2026-00415
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    January 1, 2026
    Report Date
    February 17, 2026
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    TARIQ PARKER, EMMANUEL MENSAH, KHALIL ST. BRICE, JOSHUA CHALIF, WILLIAM BUTLER, KRISTOPHER KAHLE. SAFETY OF ELECTROCONVULSIVE THERAPY WITH IMPLANTED VENTRICULAR SHUNTS A SYSTEMATIC REVIEW AND CASE SERIES. JOURNAL OF ECT 0 (2026). DOI: 10.1097/YCT.0000000000001171 OBJECTIVES: WE AIM TO DETERMINE THE SAFETY AND OUTCOMES OF ELECTROCONVULSIVE THERAPY (ECT) IN PATIENTS WITH VENTRICULAR SHUNTS, WITH A FOCUS ON SHUNT FUNCTION AFTER TREATMENT. METHODS: WE CONDUCTED A RETROSPECTIVE ANALYSIS OF ALL PATIENTS WITH VENTRICULOPERITONEAL SHUNTS WHO UNDERWENT ECT AT THE MASSACHUSETTS GENERAL HOSPITAL BETWEEN NOVEMBER 2021 AND NOVEMBER 2024. WE ALSO CONDUCTED A SYSTEMATIC REVIEW OF THE LITERATURE TO IDENTIFY ALL STUDIES PUBLISHED BETWEEN NOVEMBER 1, 1964, AND NOVEMBER 1, 2024, REPORTING THE USE OF ECT IN PATIENTS WITH IMPLANTED CEREBROSPINAL FLUID SHUNTS. RESULTS: OUR CASE COHORT COMPRISED 4 PATIENTS WITH IMPLANTED PROGRAMMABLE VP SHUNTS, OF WHICH, 2 CASES DEMONSTRATED EVIDENCE OF VALVE SETTING CHANGES AFTER ECT. ACROSS ALL THE CASES, ECT WAS EFFECTIVE IN REDUCING PSYCHIATRIC SYMPTOMS WITHOUT EVIDENCE OF SHUNT MALFUNCTION, ALBEIT WITH SOME ECT-RELATED ADVERSE SIDE EFFECTS. OUR SEARCH YIELDED 115 STUDIES, OF WHICH 12 MET THE INCLUSION CRITERIA FOR REVIEW. THESE STUDIES DESCRIBED THE SUCCESSFUL ADMINISTRATION OF ECT IN PATIENTS WITH IMPLANTED CEREBROSPINAL FLUID SHUNTS, WITH NO REPORTS OF SHUNT MALFUNCTION OR REQUIREMENT FOR REVISION. CONCLUSIONS: ECT APPEARS TO BE A SAFE AND EFFECTIVE TREATMENT FOR PSYCHIATRIC PATIENTS WITH INDWELLING VENTRICULAR SHUNTS. ECT ADMIN ISTERED TO PATIENTS WITH PROGRAMMABLE SHUNT VALVES REQUIRE PARTICULAR ATTENTION WITH EVALUATION FOR SHUNT SETTING CHANGES AND REPROGRAMMING TO PRE-ECT SETTINGS WHEN APPROPRIATE. OUR FINDINGS SUPPORT THE NEED FOR A MULTIDISCIPLINARY APPROACH, INVOLVING PSYCHIATRY, ANESTHESIA, AND NEUROSURGICAL TEAMS, TO MITIGATE RISKS AND OPTIMIZE CARE IN THIS UNIQUE PATIENT POPULATION. REPORTED EVENTS - AN ELDERLY MALE WITH A HISTORY OF NPH HAD A RIGHT OCCIPITAL VP (VENTRICULOPERITONEAL) SHUNT WITH A STRATA VALVE (MEDTRONIC, MINNEA POLIS, MN) PLACED 1 YEAR BEFORE STARTING ECT. HIS PSYCHIATRIC HISTORY INCLUDED ANXIETY AND TREATMENT-RESISTANT DEPRESSION, WITH INCONSISTENT RESPONSES TO ECT BEFORE SHUNT PLACEMENT. HE RECEIVED RIGHT UNILATERAL ECT WITH A PULSE WIDTH OF 0.4 MS AND CURRENT 800 MA. HIS INITIAL ECT SESSION WAS ADMINISTERED AT A FREQUENCY OF 40 HZ, STIMULUS DURATION 3 SECONDS, AND CHARGE OF 76.8 MC WITH SUBSEQUENT UP TITRATIONS TO 80 HZ, 8 SECONDS, AND 409.6 MC FOR THE REMAINDER OF HIS ECT SESSIONS. THE DURATION OF ELECTROENCEPHALOGRAPHIC SEIZURE DURING ECT SESSIONS RANGED FROM 65 TO 110 SECONDS, WHILE THE DURATION OF MOTOR SEIZURES REMAINED FAIRLY CONSISTENT AMONG SESSIONS BETWEEN 39 AND 40 SECONDS. ROUTINE CHECKS WERE PERFORMED ON THE SHUNT SETTING DURING HIS 4 ECT SESSIONS, WITH NO CHANGES TO VALVE SETTINGS NOTED. ALTHOUGH NO SHUNT SETTING CHANGES WERE DETECTED AFTER ECT, A MAGNETIC RESONANCE IMAGING (MRI) CONDUCTED INDEPENDENT OF HIS ECT SESSIONS DID REVEAL A DEVIATION IN THE SHUNT SETTING, REQUIRING REPROGRAMMING. AFTER THE FOURTH SESSION, THE PATIENT DEVELOPED SIGNIFICANT DELIRIUM, WITHOUT EVIDENCE OF CHANGE IN SHUNT FUNCTION, RAISING CONCERNS FOR POST-ECT ENCEPHALOPATHY. THE DELIRIUM RESOLVED WITH CONSERVATIVE MANAGEMENT, BUT DUE TO THE SEVERITY OF THE SIDE EFFECTS, FURTHER ECT SESSIONS WERE DISCONTINUED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423634 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC DOMINICANA UNKNOWN-S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male